Randomized Double Blinded Study Evaluating CACICOL20 Efficiency Versus Placebo Corneal Chronic Ulcers Healing (UNICOL)

This study has been completed.
Sponsor:
Collaborator:
Assistance Publique - Hôpitaux de Paris
Information provided by (Responsible Party):
Organ, Tissue, Regeneration, Repair and Replacement
ClinicalTrials.gov Identifier:
NCT01242839
First received: September 3, 2010
Last updated: May 4, 2016
Last verified: May 2016
  Purpose

CACICOL20 is a biodegradable nanopolymer engineered to mimic glycosaminoglycans such as heparan sulfates. Applied to the corneal lesion, it replaces damaged heparan sulfates in the matrix scaffold. CACICOL20 binds to matrix proteins such as collagen and cytokines or endogenous growth factors of the cellular microenvironment. CACICOL20 provides a protective function and restores the matrix architecture. This produces a suitable spatial environment for cells to respond properly to the cascade of signals needed for tissue regeneration to resume.

The ophthalmic solution, CACICOL20, used for corneal ulcers is very well tolerated both locally and generally, as proved by a pilot study which as been conducted at the "Hôpital des XV-XX" in Paris (France). It reduces the pain significantly and increases corneal ulcer healing (all ulcers treated were resistant to all other usual therapies).

Therefore, the accuracy of a Randomized multicentric double blinded study to evaluate the efficacy of CACICOL20 versus placebo for chronic corneal ulcer healing has been shown and will begin mid-may 2010. In this study, CACICOL20 will be applied every 2 or 4 days for 3 months.

The aim of the study is a double blinded comparison of complete chronic corneal ulcers healing rate within 3 months in 3 groups of patient double blinded randomized between CACICOL20 instillations distribution and physiological salt solution instillations distribution.

The main judgment criteria is healing rate within 3 months defined as corneal ulcer complete closure.


Condition Intervention
Corneal Ulcer
Device: CACICOL20
Device: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Multicentric Double Blinded Study Evaluating CACICOL20 Efficiency Versus Placebo Corneal Chronic Ulcers Healing

Resource links provided by NLM:


Further study details as provided by Organ, Tissue, Regeneration, Repair and Replacement:

Primary Outcome Measures:
  • Healing rate [ Time Frame: Within 1 months ] [ Designated as safety issue: No ]
    The main judgment criteria is healing rate within 3 months defined as corneal ulcer complete closure.


Secondary Outcome Measures:
  • Healing rate [ Time Frame: 2 and 3 months ] [ Designated as safety issue: No ]
    Complete Healing rate of the ulcer at 1 and 2 months defined as corneal ulcer complete closure, the evaluation of the pain with visual pain scale and evaluation of the quotation of analgesic treatments used by the patient.

  • Visual pain scale [ Time Frame: 1, 2 and 3 months ] [ Designated as safety issue: No ]
    Complete Healing rate of the ulcer at 1 and 2 months defined as corneal ulcer complete closure, the evaluation of the pain with visual pain scale and evaluation of the quotation of analgesic treatments used by the patient.

  • Associated treatments quotation [ Time Frame: 1, 2 and 3 months ] [ Designated as safety issue: No ]
    Quotation of analgesic treatments used and assessment of the effects of lubricant eye drops on the patient.


Enrollment: 139
Study Start Date: April 2010
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CACICOL20
Arm that receives CACICOL20 treatment each 2 days for 3 months/until closure of the ulcer
Device: CACICOL20
CACICOL20 is a solution of dextran & poly(carboxymethylglucose sulphate)in physiological salt serum. CACICOL20 is presented in 0.33 mL strip. One drop is instilled at each application to impregnate cornea.
Placebo Comparator: Placebo
The placebo is applicated each 2 days on patient cornea for 3 months/ until ulcer closure.
Device: Placebo
It is the placebo of CACICOL20, containing dextran in physiological serum salt. It is presented, like CACICOL20, in a 0.33 mL strip. One drop is delivered at each application.
Experimental: CACICOL20 and Placebo
Patient applies the treatment each 2 days for 3 months or until closure of the ulcer. This treatment is alternatively CACICOL20 or Placebo : so the patient receives CACICOL20 each 4 days. CACICOL20 and placebo strips are strictly similar and cannot be identified.
Device: CACICOL20
CACICOL20 is a solution of dextran & poly(carboxymethylglucose sulphate)in physiological salt serum. CACICOL20 is presented in 0.33 mL strip. One drop is instilled at each application to impregnate cornea.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with non-infectious, corneal chronic ulcer, painful or not ,whose depth does not exceed the superficial stroma.
  • Resistance of corneal pathology to standard treatment: eye drops to promote healing, tear substitutes, anti-inflammatory drugs, cyclosporin.
  • Patients previously treated for the corneal pathology, assessed ineffective or Insufficiently effective by the investigator
  • Patients using wetting gel or eye drops without conservator during the inclusion
  • Anti-inflammatory local treatments must be stopped for at least 8 days.
  • No contact lenses or lenses must be removed for at least 8 days.
  • Age of inclusion ≥ 18 years.
  • Written and signed informed consent from patient.
  • Realization of a preliminary medical examination.
  • Covers by social insurance

Exclusion Criteria:

  • Ulcers deeper than the superficial stroma, perforated ulcers or pre-perforated
  • Corneal abscess
  • Infectious and progressive ulcerative keratitis
  • Patients receiving anti-inflammatory eye drops or steroid with cyclosporine treatment (in this case, possibility of inclusion in the clinical protocol after a Case "wash-out of 8 days)
  • Patients on long-term eye drops containing preservatives and can not be stopped or replaced by an equivalent without preservatives
  • Patients on systemic anti-inflammatory, anti-allergic, psychotropic or antibiotics therapies, modified since less than 10 days or likely to be on short-term
  • Wearing contact lenses if patient has not been stopped at least eight days before the start of the protocol
  • ocular surgery within the last 3 months
  • patient already included in another clinical trial with an investigational product
  • Pregnant patients or breastfeeding
  • Person under a legal protection measure, under guardianship
  • Unable to follow up medical examinations for geographical, social or psychological reasons
  • Not cover by social insurance.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01242839

Locations
France
Centre Hospitalier Universitaire Amiens
Amiens, France, 80054
CHU Angers
Angers, France, 49933
Hopital Avicennes
Bobigny, France, 93009
Centre Hospitalier Ambroise Paré
Boulogne Billancourt, France, 92100
Hôpital Gabriel Montpied - CHU Clermont Ferrand
Clermont Ferrand, France, 63003
Centre Hospitalier Universitaire de Dijon
Dijon, France, 21079
Hôpital BICETRE
Le Kremlin-bicetre, France, 94275
CHRU Lille Hôpital Huriez
Lille, France, 59037
CHU Limoges, Hôpital Dupuytren
Limoges, France, 87042
CHU LYON, Hôpital Edouard Herriot
Lyon, France, 69003
AP-HM Hôpital de la Timone
Marseille, France, 13385
Centre Hospitalier Universitaire de Nantes
Nantes, France, 44093
Fondation Ophtalmologique Adolphe de Rothschild
Paris, France, 75019
AP-HP Hôpital Hôtel-Dieu
Paris, France, 75181
Centre Hospitalier des Quinze Vingt
Paris, France, 75571
Hôpital BICHAT - CLAUDE-BERNARD
Paris, France, 75877
CHU Hopitaux de Rouen
Rouen, France, 76031
CH Saint Louis, Saint Jean d'Angély
Saint Jean d'Angély, France, 17415
Centre Hospitalier Universitaire de Saint-Etiennne
Saint-Etienne, France, 42055
Hopitaux Universitaires de Strasbourg
Strasbourg, France, 67091
Centre Hospitalier Universitaire de Tours
Tours, France, 37044
Sponsors and Collaborators
Organ, Tissue, Regeneration, Repair and Replacement
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Christophe Baudouin, MD XV- XX Hospital - Paris
  More Information

Responsible Party: Organ, Tissue, Regeneration, Repair and Replacement
ClinicalTrials.gov Identifier: NCT01242839     History of Changes
Other Study ID Numbers: CT08L06UC 
Study First Received: September 3, 2010
Last Updated: May 4, 2016
Health Authority: France: ANSM - French Medicines and Health Products Safety Agency

Keywords provided by Organ, Tissue, Regeneration, Repair and Replacement:
CACICOL20

Additional relevant MeSH terms:
Ulcer
Corneal Ulcer
Pathologic Processes
Eye Infections
Infection
Keratitis
Corneal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on August 25, 2016